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| Product NDC Code | 50066-056 | ||||
|---|---|---|---|---|---|
| Drug Name | Dragon pain numbing topical analgesic |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1010895 | ||||
| Application Number | part348 | ||||
| Labeler Name | Genomma Lab USA Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Lidocaine HCl 4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions ◆ use only as directed Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol denat., Aminomethyl propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Decolorized Aloe barbadensis leaf juice, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearare SE, Phenoxyethanol, Steareth-21, Water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for the temporary relief of pain
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Dragon Pain Numbing Topical Analgesic LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ALCOHOL AMINOMETHYLPROPANOL CAPRYLYL TRISILOXANE CETOSTEARYL ALCOHOL Ceteth-20 Phosphate ALOE VERA LEAF DIHEXADECYL PHOSPHATE Dimethicone EDETATE DISODIUM Ethylhexylglycerin Glyceryl Stearate SE Phenoxyethanol Steareth-21 Water
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 76.5 g Bottle Carton POMADA DRAGON ® LIDOCAINE HCl 4% MAX STRENGTH PAIN NUMBING CREAM BLOCKS PAIN RECEPTORS Numbs pain fast Hours of relief Odor free NET. WT 2.7 oz (76.5 g) PRINCIPAL DISPLAY PANEL - 76.5 g Bottle Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Distributed by: Genomma Lab USA, Inc., Houston, TX 77027
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use ◆ on large areas of the body or on raw or blistered skin ◆ on wounds or damaged skin
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children to avoid accidental ingestion . If swallowed, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call toll free 1 877 99 GENOM (43666)
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if ◆ conditions worsen or symptoms persist for more than 7 days ◆ symptoms clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product ◆ use only as directed ◆ do not use in large quantities ◆ avoid contact with eyes ◆ do not apply tight bandages ◆ do not apply a heating pad to treated skin
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information ◆ Store at room temperature ◆ Close cap tightly after use
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Do not use ◆ on large areas of the body or on raw or blistered skin ◆ on wounds or damaged skin When using this product ◆ use only as directed ◆ do not use in large quantities ◆ avoid contact with eyes ◆ do not apply tight bandages ◆ do not apply a heating pad to treated skin Stop use and ask a doctor if ◆ conditions worsen or symptoms persist for more than 7 days ◆ symptoms clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children to avoid accidental ingestion . If swallowed, get medical help or contact a Poison Control Center immediately.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API